Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the role of an integrated strategy at selecting fetuses for delivery at term based on a combination of fetal biometry and cerebroplacental ratio (CPR) to reduce stillbirth rate and adverse perinatal outcome.
This is a multicenter, open-label randomized trial with groups in parallel. Singleton pregnancies are recruited after routine second trimester scan (19+0 to 22+6 weeks of gestation) and randomly allocated at that moment to revealed or concealed strategy. A routine scan will be booked at 36-37 weeks. For a reduction of the stillbirth rate of 3‰ (from 5‰ to 2‰), assuming a type I error of 5% and aiming for a power of 80% a total of 11,582 subjects (5791 per arm) were projected. The participating centers sum up 12,000 deliveries a year. It is not possible to blind participants, obstetricians, or outcome assessors to the study group.
General hypothesis: A proportion of fetuses with "normal" growth as per current standards have placental insufficiency and restriction of their growth potential. These fetuses exhibit biophysical changes expressed by abnormal cerebroplacental ratio. A combination of this marker with fetal biometry for the detection of fetuses affected by fetal growth restriction could identify a group of babies on which labor induction once term is reached may prevent the occurrence of adverse outcomes.
Specific hypothesis
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concealment | No Intervention | Cerebroplacental ratio measurement at 37 weeks of pregnancy only taken into account if estimated fetal weight \ | |
| Revealment | Other | Cerebroplacental ratio measurement at 37weeks and labor induction in case of cerebroplacental ratio \ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Revealment | Other | Cerebroplacental ratio revealment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stillbirth | Perinatal death | between 37 and 42 weeks of pregnancy |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse perinatal outcome | Severe neurological and non-neurological adverse outcome | Up to 28 days after delivery |
| Fetal Growth Restriction Detection | To detect prenatal low birth weight |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eduard Gratacos, PhD | Hospital Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClĂnico Universitario de Santiago de Chile | Santiago | Chile | ||||
| Palacky University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38219773 | Derived | Rial-Crestelo M, Lubusky M, Parra-Cordero M, Krofta L, Kajdy A, Zohav E, Ferriols-Perez E, Cruz-Martinez R, Kacerovsky M, Scazzocchio E, Roubalova L, Socias P, Haslik L, Modzelewski J, Ashwal E, Castella-Cesari J, Cruz-Lemini M, Gratacos E, Figueras F; RATIO37 Study Group. Term planned delivery based on fetal growth assessment with or without the cerebroplacental ratio in low-risk pregnancies (RATIO37): an international, multicentre, open-label, randomised controlled trial. Lancet. 2024 Feb 10;403(10426):545-553. doi: 10.1016/S0140-6736(23)02228-6. Epub 2024 Jan 11. | |
| 28619771 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D050497 | Stillbirth |
| D005317 | Fetal Growth Retardation |
| ID | Term |
|---|---|
| D005313 | Fetal Death |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 3 years |
| Olomouc |
| Czechia |
| Ladislav Krofta | Prague | Czechia |
| Eyal Zohav | Tel Aviv | Israel |
| Hospital de Querétaro | Querétaro | Mexico |
| Anna Kajdy | Warsaw | Poland |
| Hospital Clinic | Barcelona | 08036 | Spain |
| Elena Escazzocchio | Barcelona | Spain |
| Elena Ferriols Perez | Barcelona | Spain |
| Derived |
| Figueras F, Gratacos E, Rial M, Gull I, Krofta L, Lubusky M, Cruz-Martinez R, Cruz-Lemini M, Martinez-Rodriguez M, Socias P, Aleuanlli C, Cordero MCP. Revealed versus concealed criteria for placental insufficiency in an unselected obstetric population in late pregnancy (RATIO37): randomised controlled trial study protocol. BMJ Open. 2017 Jun 15;7(6):e014835. doi: 10.1136/bmjopen-2016-014835. |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005315 | Fetal Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006130 | Growth Disorders |